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临床试验/CTRI/2025/12/099623
CTRI/2025/12/099623尚未招募不适用

Oral Probiotics vs Standard Antibiotic Therapy for Bacterial Vaginosis- A Randomised, Double Blind, Clinical Study

Dr Sakshi Chandak1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
RECURRENCE OF BACTERIAL VAGINOSIS BY ASSESSING NUGENT SCORE (IF ABOVE SEVEN) OR AMSELS CRITERIA POSITIVE

研究概览

简要总结

Bacterial Vaginosis is a polymicrobial syndrome where the lactobacilli-dominated vaginal microflora is replaced by a mix of other, mainly anaerobic bacteria species. Renewed attention has recently been focused on approaches involving alternative ‘natural’ treatments that could be effective in the microbiological and clinical resolution of the condition without side effects. A meta-analysis involving 10 RCTs with a low or moderate risk of bias, suggested that the treatment with probiotics alone was more effective in the therapy of Bacterial Vaginosis for both short- and long-term; however, the probiotics used after antibiotic treatment was effective only for a short term

Thus, probiotics rather than antibiotics have promising results in reducing the recurrence rate of bacterial vaginosis

Thus, the aim of the study is ’to compare the efficacy of standard therapy vs oral probiotics in women with bacterial vaginosis’

100 women with bacterial vaginosis will be randomised into 2 equal groups and each group will be given either oral probiotics or Metronidazole(standard treatment) and assessed after 30 days to see for recurrence of bacterial vaginosis.

Hypothesis: Probiotics confer long term benefit for treatment of Bacterial Vaginosis as compared to Standard Antibiotics.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Consenting women in age group of 18-45 years,
  • Presenting with discharge per vaginum.

排除标准

  • Pregnant women
  • Women with any other vaginal or cervical pathology like cervical polyp, cervical erosion, carcinoma cervix, etc.
  • Women who have had previous treatment for Bacterial vaginosis
  • Menstruating at the time of examination.

结局指标

主要结局

RECURRENCE OF BACTERIAL VAGINOSIS BY ASSESSING NUGENT SCORE (IF ABOVE SEVEN) OR AMSELS CRITERIA POSITIVE

时间窗: After 30 days of giving treatment

次要结局

  • 1. patients’ satisfaction by life style questionnaire(After 30 days of giving treatment)
  • 2. Side effects(After 30 days of giving treatment)

研究者

发起方
Dr Sakshi Chandak
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sakshi Chandak

Datta Meghe Institite of Higher Education And Research(du)

研究点 (1)

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